Associate Director, Pharmacovigilance in United States at Jobgether
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Job Description
This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Associate Director, Pharmacovigilance in United States.
This role offers a key leadership opportunity within clinical safety, supporting the development of innovative therapies for patients with severe autoimmune diseases. As Associate Director, Pharmacovigilance, you will play a central role in ensuring patient safety and regulatory compliance across ongoing clinical trials. You will collaborate closely with safety physicians, clinical development teams, and external partners to evaluate and manage safety data. The position involves active participation in safety governance processes, including DSMB and safety review activities, while ensuring high-quality data oversight. You will contribute directly to the interpretation of adverse events, safety signals, and benefit–risk assessments. This is a highly collaborative and fast-paced role suited for a detail-oriented pharmacovigilance professional who thrives in clinical development environments.
- Oversee pharmacovigilance activities for assigned clinical programs, ensuring compliance with global regulatory standards and internal procedures
- Review and assess adverse event reports, including serious adverse events, ensuring accuracy, consistency, and timely regulatory reporting
- Ensure high-quality safety data review and coordinate reconciliation between safety databases and clinical trial data systems
- Contribute to the preparation and review of clinical study documents, including protocols, investigator brochures, and clinical study reports
- Lead and support the planning, coordination, and execution of DSMB and Safety Review Committee (SRC) meetings, including materials preparation and documentation
- Collaborate with safety physicians on signal detection, risk assessments, and benefit–risk evaluations
- Contribute to aggregate safety reporting, including DSUR preparation and related regulatory submissions
- Serve as a safety subject matter expert for internal teams and external stakeholders
- Ensure proper documentation and oversight of pharmacovigilance quality events, including deviations, CAPAs, and change controls
- Maintain accurate meeting records, safety documentation, and compliance with global pharmacovigilance regulations
Requirements:
- PharmD or Registered Nurse (RN) degree required
- Experience in pharmacovigilance or clinical development within the pharmaceutical or biotech industry
- Proven experience reviewing adverse events and working closely with safety physicians
- Hands-on experience supporting DSMB and SRC processes and safety reporting deliverables
- Strong understanding of global pharmacovigilance regulations, including FDA, EMA, and ICH guidelines
- Proficiency in safety databases such as Argus
- Strong analytical, organizational, and communication skills
- Ability to manage multiple priorities in a fast-paced, start-up or small biotech environment
- Proficiency with Microsoft Office Suite and collaboration tools such as Microsoft Teams
- Experience in rare disease or oncology programs is a plus
- Prior experience in early-stage biotech or high-growth environments is highly desirable
Benefits:
- Competitive compensation package aligned with experience and industry standards
- Opportunity to contribute to innovative therapies in autoimmune disease treatment
- Remote work flexibility within the United States
- Exposure to high-impact clinical development programs in a fast-growing biotech environment
- Collaborative and mission-driven culture focused on patient outcomes
- Professional growth opportunities in pharmacovigilance and clinical safety leadership
- Dynamic, science-driven workplace with cross-functional collaboration.